Foresee Pharmaceuticals Receives the Third Positive Recommendation from the DSMB to Continue the Casppian Study

The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg- controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). Foresee's leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI^®), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer.

The third favorable review from the DSMB, received after reaching nearly 75% enrollment in the Casppian trial, reinforces the promising safety data for FP-001 42 mg administered every six months in children with CPP. Early efficacy signals further support our confidence that this therapy could represent a groundbreaking advancement for pediatric patients with CPP. We are committed to swiftly completing enrollment while upholding the utmost safety and ethical rigor standards throughout this pivotal study.

said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development of Foresee.  

This DSMB recommendation again highlights the effectiveness of Foresee's innovative Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology across several disease indications, including in children with CPP.

said Dr. Yuhua Li, Chief Technology Officer of Foresee.

The outcome from the third DSMB for the Casppian study represents a major advancement in our mission to enhance the standard of care and improve the quality of life for children with CPP. This positive recommendation moves us nearer to our objective of providing safe and effective treatments for children in need, as well as to the anticipated top-line results from this trial, expected in 2025.